JP2023504325A - Intravenous catheter device - Google Patents

Abstract

An intravenous (IV) catheter (10) device includes a tubular catheter (14) having a proximal end (18) and a distal end (20) and attached to a catheter hub (12) and a shaft A needle (21) defining a direction (A), a wall defining a lumen (26), a bevel (34), a needle shaft (22) having a needle tip (24) at the distal end (20). ), and a needle (21) comprising a needle hub (16) attached to the proximal end (18) of the needle shaft (22) and a needle guard (38) movably disposed on the needle shaft (22). ), wherein the needle shaft (22) extends within the tubular catheter (14) and the needle tip (24) of the needle (21) extends into the tubular catheter (14). Projecting from the distal end (20), the needle (21) engages the needle guard (38) to prevent the needle tip (24) from slipping out of the needle guard (38). The needle (21) has at least one opening (28) with at least one beveled cut (32). [Selection drawing] FIGS. 1A and 1B

Description

The present invention relates generally to needle devices, systems, and methods used to administer drugs to or withdraw blood from patients. More specifically, the present disclosure relates to intravenous (IV) catheter devices or assemblies. In particular, the present invention relates to the configuration of the opening provided in the needle near the needle tip, the distance between the needle tip and the opening being such that the opening is covered by the catheter tube when the needle is in the ready position. configured as Using such an opening, the physician receives immediate feedback as to whether the patient has been successfully venipunctured by a so-called flashback function.

Intravenous (IV) catheter devices with needles having needle guards are generally known and are used, for example, to administer drugs to or withdraw blood from patients. Intravenous (IV) catheter devices typically include a tubular catheter having proximal and distal ends and a needle defining an axial direction and having a needle shaft and a needle tip at the distal end of the needle shaft. a needle shaft extending through the catheter with a needle tip projecting from the distal end of the tubular catheter; and the needle shaft comprising engaging means, the engaging means being on the needle shaft. The profile changes to engage a slidably disposed needle guard to prevent the needle tip from slipping out of the needle guard.

A needle guard helps prevent accidental contact with the tip of a needle by a person handling an intravenous catheter device after the catheter tube has been inserted into the patient's vein and the needle has been withdrawn from the patient's vein. The intravenous catheter device thereby helps avoid the unwanted transmission of blood-borne diseases.

In use, the tubular catheter is inserted into a patient's blood vessel, typically a vein, using a needle, and the needle is withdrawn from the catheter after the tubular catheter has been inserted into the blood vessel and the venipuncture has been successful. When the needle tip is inserted into a blood vessel, blood flows through the lumen of the needle and into an opening provided near the needle tip at the distal end of the needle, where the person handling the catheter device. can see the blood. The event of blood flowing out of the opening of the needle, called blood flashback, is used by those handling the catheter device to confirm venipuncture and then to prevent puncture of the posterior wall of the vessel. Decrease the inclination of the needle accordingly and insert the catheter.

If the blood flashback is delayed, there is a risk that the person handling the catheter device will continue to push the needle into the vessel in its original state of high needle tilt, causing the needle to protrude from the back side of the vessel. This second venipuncture is a risk to the patient's health as it can cause internal bleeding. In addition, the catheter device must be removed and replaced with a new one, ie the procedure of inserting the catheter must be repeated, which is uncomfortable and painful for the patient.

The contours of the openings in the needle of conventional intravenous catheter devices can cause the needle guard to jam or block such openings due to accidental rotation of the needle guard on the needle shaft. there is a problem that it can affect the proper functioning of the device. To further explain, needle guards typically include arms or jaws having ends that block the needle tip. The needle guard is slidably disposed on the needle shaft while inadvertently rotating thereon. During such rotation, alignment of the opening in the needle shaft with the arm or jaw having the needle tip block end of the needle guard could block or jam the needle guard in the opening and affect the proper functioning of the device. give. In addition, such obstruction creates resistance and friction during withdrawal of the needle after venipuncture, causing pain to the patient.

Furthermore, the configuration of the openings provided in the needle of conventional intravenous catheter devices is such that when the needle is inserted into the body, the needle may catch internal tissue within and/or at the opening, slot or hole, Another problem is that it is large enough to risk cutting and/or damaging internal tissue.

The present disclosure aims to solve these problems.

A primary object of the present invention is to provide an intravenous catheter device that is inexpensive to manufacture and provides excellent protection against accidental needle stick sticks.

Another object of the present invention is to provide an intravenous (IV) catheter system that allows for safer, more convenient and more reliable placement of a catheter within a patient's blood vessel.

Another object of the present invention is to provide a needle having at least one opening or hole near the tip that is contoured so as not to interfere with the needle guard during withdrawal of the needle after venipuncture.

Another object of the present invention is to provide a needle having at least one opening or hole near the tip that is contoured so as not to interfere with one or more arms of the needle guard during withdrawal of the needle after venipuncture. .

Another object of the present invention is to provide at least one opening or hole near the tip contoured so as not to interfere with the arm or arms having the needle tip block end of the needle guard during withdrawal of the needle after venipuncture. is to provide a needle having

Another object of the invention is for a needle, close to the needle tip, having at least one beveled cut of angle (X) of increasing value towards the proximal end of the needle in the opposite direction of the needle tip. and the angle of inclination (X) is in the range of 0° to 89°.

Another object of the invention is for a needle, close to the needle tip, having at least one beveled cut of angle (X) of increasing value towards the distal end of the needle in the direction of the needle tip. Provide at least one opening or hole, the angle of inclination (X) being in the range of 0° to 89°.

Yet another object of the present invention is to provide at least one opening or hole near the needle tip formed by two angled cuts, one of the angled cuts facing away from the needle tip. It has an angle (X) of increasing value towards the proximal end of the needle, and the second beveled cut has an angle (Y) of increasing value towards the distal end of the needle in the direction of the needle tip. ), and the angles (X) and (Y) of inclination are in the range of 0° to 89°.

Still another object of the present invention is to prevent the needle from being caught in the internal tissue inside and/or at the opening or hole and cutting and/or damaging the internal tissue when the needle is inserted into the human body. providing at least one opening or hole of sufficient size so as not to pose a risk of

The intravenous catheter device of the present invention comprises:
a catheter hub disposed at the proximal end of the catheter tube and having an inner surface defining a chamber;
a needle defining an axial direction and having a needle tip, the needle extending through the chamber and the catheter tube in the ready position;
A needle guard slidably disposed over the needle and at least partially contained within the chamber when the needle is in the ready position, the needle guard comprising a base portion and first and second extending from the base portion. a needle guard comprising an arm, wherein when the needle is in a ready position, the first arm is deflected radially outward by the needle against a restoring force to force the needle guard out of contact with the catheter hub; hold and
Retaining means are provided for retaining the needle guard within the chamber while the needle tip is contained within the needle guard and for safely securing or capturing the needle tip within the needle guard.

One aspect of the present invention relates to an intravenous (IV) catheter device comprising:
a tubular catheter having a proximal end and a distal end and mounted in a catheter hub;
A needle defining an axial direction (A), a wall defining a lumen, a bevel, a needle shaft having a needle tip at a distal end, and located at the proximal end of the needle shaft. a needle comprising a needle hub configured to
a needle guard movably arranged on the needle shaft,
the needle shaft extends through the tubular catheter such that the needle tip of the needle protrudes from the distal end of the tubular catheter;
the needle comprises engagement means adapted to engage the needle guard to prevent the needle tip from slipping out of the needle guard;
The needle has at least one opening or hole with at least an angled cut.

In another aspect of the invention, the needle includes a needle shape near the needle tip that changes the cross-sectional shape of the needle. Such a needle shape may be an engagement means with a varying profile, i.e. an enlarged cross-section of the needle, for example formed on the outer circumference of the needle shaft or added to a particular outer circumference of the needle shaft. is a peripheral bump or rip formed by a local protrusion of the material of the Alternatively, for ease of manufacture, the needle shape may be locally compressed and deformed within the needle guard so that the needle has an elliptical cross-section that does not fit into the circular opening. can be formed by

In one embodiment, the opening or hole provided in the needle shaft has at least one beveled cut with an angle (X) of increasing value towards the proximal end of the needle in the opposite direction of the needle tip. In another embodiment, the opening or hole provided in the needle shaft has at least one beveled cut with an angle (X) of increasing value towards the distal end of the needle in the direction of the needle tip. In yet another embodiment, the opening or hole is formed by two angled cuts, one of which has an angle (X ) and the second angled cut has an angle (Y) of increasing value towards the distal end of the needle in the direction of the needle tip. With or without radius (R), the angle (X) and angle (Y) of inclination are in the range of 0° to 89°. The openings have various dimensions of length (L) and width (W).

In other embodiments, the opening or hole has at least one slanted radial cut, and the radius (R) of the slanted cut has varying lengths.

In other embodiments of the invention, one or more openings or holes can be provided in the needle shaft. The functionality of the device with one or more openings or holes is the same as other embodiments disclosed herein.

The beveled cut of the aperture or hole has a suitable shape, including shapes substantially oval, oval, square, rectangular, triangular, circular, polygonal, irregular, etc. . The aperture can be positioned in the needle shaft so that it faces in a direction that is substantially the same, vertical, or offset from the direction in which the bevel of the needle faces.

The aperture or hole has a perforation-like shape that creates an opening of sufficient size for blood to flash back through it. Also, the small size of the opening does not interfere with the beveled end arm of the needle guard when withdrawing the needle from the catheter hub after a successful venipuncture. Also, due to the small size of the opening, when the needle is inserted into the human body, there is a risk that the needle will catch on internal tissue inside and/or at the opening and/or cut and/or damage internal tissue. is also guaranteed not to occur. The aperture or hole can be small compared to the length of the needle, for example the length or width of the aperture can be less than 10% and/or 20% of the length of the needle.

An opening or hole is provided in the needle shaft near the needle tip. The distance between the needle tip and the aperture is configured such that the aperture is covered by the catheter tube.

Apertures or holes can be provided at any position of the circumference of the needle shaft 360° in the opposite direction of the bevel of the needle, except at the bottom of the needle shaft.

In one embodiment, the aperture or hole has two sides, one side is straight (horizontal or vertical) and the other side is slanted.

The opening or hole can be located anywhere from proximal to the needle tip to distal to the catheter hub. In one embodiment, the aperture is provided between the engagement means and the needle tip. In another embodiment, the engagement means are provided between the needle tip and the opening.

Embodiments of the disclosure are described more fully below with reference to the accompanying drawings, in which embodiments of the disclosure are shown. This disclosure may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the claims to those skilled in the art. Like numbers refer to like components throughout. Embodiments of the invention are set forth in the following description and accompanying drawings.
1A is a cross-sectional view of an intravenous catheter device according to the present invention; FIG. FIG. 1B is a detailed view of the circled portion of FIG. 1A. FIG. 2A is a front view of the distal portion of a needle having an opening such as is commonly used for blood flashback in prior art devices. FIG. 2B is a side view of the distal portion of a needle having an aperture such as is commonly used for blood flashback in prior art devices. FIG. 2C is a detailed view of the circled portion of FIG. 2B. FIG. 3A is a front view of a distal portion of a needle with openings used for blood flashback in accordance with one embodiment of the present invention. FIG. 3B is a side view of the distal portion of a needle with openings used for blood flashback in accordance with one embodiment of the present invention. FIG. 3C is a detailed view of the circled portion of FIG. 3B. FIG. 4A is a side view of a distal portion of a needle with openings used for blood flashback in accordance with another embodiment of the present invention. FIG. 4B is a front view of the distal portion of a needle with openings used for blood flashback in accordance with another embodiment of the present invention. FIG. 5A is a side view of a distal portion of a needle with openings used for blood flashback in accordance with another embodiment of the present invention. FIG. 5B is a front view of a distal portion of a needle with openings used for blood flashback in accordance with another embodiment of the present invention. FIG. 6A is a side view of a distal portion of a needle with openings used for blood flashback in accordance with yet another embodiment of the present invention. FIG. 6B is a front view of the distal portion of a needle with openings used for blood flashback in accordance with yet another embodiment of the present invention. FIG. 7A is a side view of a distal portion of a needle with openings used for blood flashback in accordance with yet another embodiment of the present invention. FIG. 7B is a front view of the distal portion of a needle with openings used for blood flashback in accordance with yet another embodiment of the present invention. FIG. 8A is a front view of a distal portion of a needle with openings used for blood flashback in accordance with one embodiment of the present invention. FIG. 8B is a side view of the distal portion of a needle with openings used for blood flashback in accordance with one embodiment of the present invention. FIG. 8C is a detailed view of the circled portion of FIG. 8B. FIG. 9A is a side view of the distal portion of a needle with openings used for blood flashback in accordance with another embodiment of the present invention. FIG. 9B is a front view of the distal portion of a needle with openings used for blood flashback in accordance with another embodiment of the present invention. FIG. 10A is a front view of the distal portion of a needle used for blood flashback and having an opening covered by a catheter tube attached to a catheter hub in accordance with one embodiment of the present invention. FIG. 10B is a side view of the distal portion of a needle used for blood flashback and having an opening covered by a catheter tube attached to a catheter hub in accordance with one embodiment of the present invention. FIG. 11A is a front view of the distal portion of a needle used for blood flashback and having an opening covered by a catheter tube attached to a catheter hub in accordance with yet another embodiment of the present invention. FIG. 11B is a side view of the distal portion of a needle used for blood flashback and having an opening covered by a catheter tube attached to a catheter hub in accordance with yet another embodiment of the present invention; FIG. 12 illustrates the needle guard of FIG. 1 according to one embodiment that is slidably arranged and advanced to protect the needle tip during withdrawal of the needle after venipuncture according to the present invention. FIG. 13 illustrates the needle guard of FIG. 1 according to one embodiment that is slidably arranged and advanced to protect the needle tip during withdrawal of the needle after venipuncture according to the present invention. Figure 14 shows another embodiment of a needle guard that can be used with the intravenous catheter device of the present invention.

Embodiments of the present invention relate to an intravenous catheter device that provides excellent protection against accidental needle tip sticks and is inexpensive to manufacture. While the invention is capable of embodiments in many different forms, this disclosure is an exemplification of the principles of the invention and is not intended to limit the invention to the embodiments detailed herein. It is with this understanding that certain embodiments are described herein.

As used herein, the term "proximal" refers to, for example, the region of or location on the device that is closest to the clinician using the device. In contrast, the term "distal" refers to the region of the device furthest from the clinician, e.g., the distal region of the needle, e.g. be.

FIG. 1A shows an example of a catheter device 10 in which a needle guard 38, similar to that disclosed in WO2018/025094, is attached to the proximal end of needle shaft 22 prior to use in the ready position. It is placed in catheter hub 12 near 18 . In this case, the needle 21 extends completely within the needle guard 38, thereby extending the first arm 42 of the needle guard outwards, i.e. relative to the axial direction A, as shown in FIGS. , and the distal wall or angled end 56 of the first arm 42 is supported on the needle shaft 22 . In one embodiment, at least one of arms 42 , 44 has a needle tip block end, eg, angled end 56 . In another embodiment, both arms 42, 44 of needle guard 38 may have an angled end 56 at the needle tip block end, eg, the distal end. After the catheter 14 is inserted into the patient, a successful venipuncture is confirmed by blood visible through an opening or hole 28 in the needle 21 near the needle tip 24, as shown in FIG. 1B. As a result, the intravenous catheter device 10 allows for more rapid confirmation of a successful venipuncture and a more reliable confirmation of such confirmation, thus providing both the person placing the catheter device and the patient in which the catheter device is used. facilitating the handling of the catheter device. Needle 21 is then withdrawn from catheter tube 14 and needle guard 38 is held on catheter hub 12 while needle shaft 22 moves through needle guard 38 . Once the needle tip 24 has passed the lateral distal wall 56 of the needle guard 38, i.e. the needle shaft 22 no longer supports the distal wall 56, the restoring force causes the first arm 42 of the needle guard 38 to move. , positively returns to align with the axial direction A of the needle guard 38, and the needle tip 24 is stopped by the distal wall 56 of the needle guard 38, i.e., the needle tip 24 extends axially from the needle guard 38. prevent protruding. The needle tip 24, which is secured and protected by the needle guard 38, is then withdrawn from the catheter hub 12 so that the needle guard 38 provides excellent protection against accidental sticks, thereby allowing the catheter device to operate. Increased safety for those handling 10.

The present invention is not limited to only one particular type of needle guard. The present invention can be used with various types of needle guards having needle tip block ends, for example, as shown in FIGS. Many other embodiments are disclosed and contemplated herein. Additionally, it should be noted that the present invention is not limited to safety IV catheters, but is applicable to a variety of needle products.

2A and 2B, front and side views, respectively, of the distal portion of needle 21 having an opening or hole 28 commonly used for blood flashback in prior art devices are shown. FIG. 2C is a detailed view of the circled portion of FIG. 2B. Aperture 28 has a rectangular cut with two corners, which has a length defined by L and a width defined by W. Width W is shorter than length L. 16 and 17, the contour of the opening 28 of the needle 21 of FIG. It has been found that the corners of such openings 28 can cause the arms of the needle guard 38 to catch or jam due to accidental rotation of the . Such interference may affect the proper functioning of device 10 . Moreover, such interference may create resistance or friction in retracting needle 21 after venipuncture.

3A and 3B, front and side views, respectively, of a distal portion of a needle 21 having at least one opening or hole 28 used for blood flashback in accordance with one embodiment of the present invention. It is shown. A needle 21 having a distal end 20 and a proximal end 18 extends through the chamber of catheter hub 12 and through catheter tube 14 . To improve visibility of blood exiting needle 21 through opening 28, catheter tube 14 advantageously comprises a transparent material. Needle hub 16 is attached to proximal end 18 of needle 21 . As can be seen, the opening or hole 28 has two sides, one side being straight (horizontal or vertical) and the other side being slanted.

Further, as can be seen, the needle 21 comprises a wall defining a lumen 26, a needle shaft 22 and a needle tip 24 at its distal end 20, extending longitudinally (A). stipulate. The needle 21 includes an opening 28 near the needle tip 24 for rapid blood flashback, as shown in FIGS. The distance between the needle tip 24 and the opening 28 is configured such that the opening 28 is covered by the catheter tube 14 attached to the catheter hub 12 when the needle 21 is in the ready position.

In order to make insertion of the catheter tube 14 into the patient's blood vessel smoother and more convenient, the catheter tube 14 is slightly tapered in the region of its distal end 20, thereby allowing the catheter tube 14 to A distal end 20 tightly surrounds the needle. Thus, the distal portion of catheter tube 14 tapers inwardly to form an opening of a size smaller than the outer diameter of needle 21 and seals around the opening of needle 21 and catheter tube 14 . and prevents fluid from entering the space 30 between the catheter tube 14 and the needle 21 as the needle tip 24 penetrates the patient's skin. To this end, the outer diameter of needle shaft 22 is made slightly smaller than the inner diameter of catheter tube 14 to provide a small gap forming space 30 between needle shaft 22 and catheter tube 14 . should be understood.

Aperture 28 is positioned near needle tip 24 to the extent that at least a portion of aperture 28 or the entirety of aperture 28 is not inserted into the patient during venipuncture. The location of aperture 28 is chosen such that it is visible to the user while performing a venipuncture. Thus, opening 28 can be located anywhere from proximal to needle tip 24 to distal to catheter hub 12 .

Through opening 28, the physician receives immediate feedback on whether the patient has been successfully treated by a so-called flashback function. The flashback feature allows a small amount of blood to flow through the opening 28 into the transparent catheter tube 14 during venipuncture, and in the space 30 between the catheter tube 14 and the needle 21, allowing the physician to push the needle tip into the patient's vein. It is immediately visible whether the insertion of part 24 was successful or not. Blood entering the space 30 between the needle shaft 22 and the catheter tube 14 expands into the space 30 by capillary action and is visible through the transparent material of the catheter tube 14, thereby indicating a successful venipuncture. It can be confirmed quickly.

As can be seen, the opening or hole 28 has at least one beveled cut 32 with an angle of increasing value towards the proximal end 18 of the needle 21 in the opposite direction of the needle tip 24 . With or without a radius, the tilt angle defined by X in FIG. 3C varies and ranges from 0° to 89°. Aperture 28 has a length defined by L and a width W. As shown in FIG. The dimensions of L and W can vary. The shape of the angled cut 32 of the opening 28 may be substantially any suitable shape, including shapes such as oval, elliptical, square, rectangular, triangular, circular, polygonal, irregular, and the like. For example, FIG. 3C shows one embodiment in which the beveled cut 32 of the opening 28 is substantially oblong.

A tip 24 of needle 21 forms a bevel 34 . Aperture 28 is typically located on one side of needle shaft 22 such that bevel 34 of needle 21 at needle tip 24 faces upward. However, the position of opening 28 can be at various positions relative to the face of bevel 34 of needle 21 . Apertures 28 may also be located on multiple sides of needle shaft 22 . Thus, opening 28 may be oriented substantially in the same direction, opposite, perpendicular to the direction in which bevel 34 of needle 21 faces, or in a direction substantially offset from the direction in which bevel 34 of needle 21 faces. , can be arranged on the needle shaft 22 . Thus, the openings or holes 28 can be provided at any 360° position around the needle shaft 22 , in the direction opposite the bevel 34 of the needle 21 , other than at the bottom of the needle shaft 22 .

In this regard, it should be understood that each component of needle 21 may have any suitable characteristics required of an introducer needle within intravenous catheter system 10 . For example, the distal tip 24 of the needle 21 may have a standard bevel, a short bevel, a very short bevel, an angled bevel, a bias grind point, a vet point, a lancet point, a deflection point (anti-coring). , or another suitable known or novel needle point. Additionally, lumen 26 and elongated tubular shaft 22 may be any suitable size required for intravenous catheter device 10 . For example, needle 21 may be of any suitable length or size for use as an introducer needle in an IV assembly.

As shown in FIGS. 16 and 17, the beveled angle of the opening 28 facilitates passage of the arms 42, 44 of the needle guard 38, and the needle guard 38 is configured to be slidable so as to withdraw the needle 21 after venipuncture. Then, proceed to protect the needle tip 24 . Therefore, even when the needle guard 38 rotates over the needle 21, and even when the opening 28 and the arms of the needle guard 38 align with the path of the needle guard 38 from the ready position to the protected position, the tilt angle of the opening 28 is an obstacle. does not become

4A and 4B, which are respectively side and distal views of a needle 21 having at least one opening or hole 28 used for blood flashback in accordance with another embodiment of the present invention. It is a front view. This embodiment is the embodiment described above in that the opening 28 has at least one beveled cut 32 with an angle of increasing value towards the distal end 20 of the needle 21 in the direction of the needle tip 24 . different from With or without radius R, the tilt angle defined by X in FIG. 4A can vary and can range from 0° to 89°. The aperture has a length defined by L and a width defined by W, each of which may be of various dimensions.

5A and 5B, side and front views, respectively, of a distal portion of a needle having at least one opening or hole 28 are shown. This embodiment differs from the previous embodiments in that the opening 28 of the needle shaft 22 is formed with two angled cuts 32 . The angled cuts 32 have a point of intersection at the center of the length L. One of the angled cuts 32 has an angle X that increases in value towards the proximal end 18 of the needle 21 in the direction opposite the needle tip 24 . On the other hand, the second angled cut 32 has an angle Y that increases in value towards the distal end 20 of the needle 21 in the direction of the needle tip 24 . With or without radius R, the tilt angle defined by X and Y in FIG. 5A can vary and can range from 0° to 89°.

6A and 6B, there are shown side and front views, respectively, of a distal portion of needle 21 having at least one opening 28 according to yet another embodiment of the present invention. As can be seen, the opening or hole 28 has at least one beveled cut 32 with an angle of increasing value towards the proximal end 18 of the needle 21 in the direction opposite the needle tip 24 . With or without radius R, the tilt angle defined by X in FIG. 6A can vary and can range from 0° to 89°.

Referring to another embodiment shown in FIGS. 7A and 7B, side and front views, respectively, of a distal portion of needle 21 having at least one opening or hole 28 are shown. This embodiment differs from the previous embodiments in that the opening or hole 28 in the needle shaft 22 is formed with two angled cuts 32 . One angled cut 32 has an angle X that increases in value towards the proximal end 18 of the needle 21 in the direction opposite the needle tip 24 . The second angled cut 32 has an angle Y that increases in value towards the distal end 20 of the needle 21 in the direction of the needle tip 24 . On the other hand, two angled cuts 32 have intersections with regions between which the regions are either straight (horizontal or vertical) or slanted. With or without radius R, the tilt angle defined by X and Y in FIG. 7A can vary and can range from 0° to 89°.

Referring to yet another embodiment shown in FIGS. 8A and 8B, front and side views, respectively, of a distal portion of needle 21 having at least one opening or hole 28 are shown. FIG. 8C is a detailed view of the circled portion of FIG. 8B. As can be seen, opening 28 has at least one beveled radius cut 32 . The radius of the angled cut 32 defined by R in FIG. 8C can be of varying lengths.

Figures 9A and 9B are side and front views, respectively, of a distal portion of a needle 21 having at least one opening or hole 28 according to another embodiment of the invention. As can be seen, opening 28 has at least one beveled radius cut 32 . The radius of this angled cut is defined by R in FIG. 9A, and the radius R of this angled cut 32 can be of various lengths.

In each of the above-described embodiments, except for at least one engaging means 36 of varying or expanding profile, which may be provided along an axial position near or far from the opening 28, as shown in FIG. 1B. , the needle shaft 22 has a generally constant primary profile. In one embodiment, aperture 28 may be provided between engagement means 36 and needle tip 24 . In an alternative embodiment, engagement means 36 may be provided between needle tip 24 and aperture 28 . Engagement means 36 are preferably made by crimping needle 21 . However, the engagement means 36 may also be made by welding, rolling, cold heading or expanding the needle 21 .

12 and 13, one embodiment of the needle guard 38 of the intravenous catheter system 10 also shown in FIG. 1 is shown. Needle guard 38 includes a base portion 40 and first and second arms 42 and 44 extending generally axially A from the distal side of base portion 40 . Base portion 40 and arms 42, 44 are integrally made of plastic material, for example by injection molding. Needle 21 extends completely within needle guard 38 in its ready position.

Referring now to FIG. 14, another embodiment of needle guard 38 usable with intravenous catheter system 10 is shown. Needle guard 38 includes a base portion 40 and first and second arms 42 and 44 extending generally axially A from the distal side of base portion 40 .

A needle 21 having an aperture as described can be used with any suitable intravenous system or device. In one example, the needle can be used with any suitable catheter assembly, including an over-needle peripheral IV catheter assembly. Therefore, the needle 21 having the opening 28 described above can be used with all medical instruments that include and use the needle 21 .

Although the terms first, second, etc. are used herein to describe various components, it is understood that these components should not be limited by these terms. These terms are only used to distinguish one component from another. For example, a first component could be termed a second component, and a second component could be termed a first component, without departing from the scope of the present disclosure. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a," "an," and "the" are intended to include plural forms as well, unless the context clearly indicates otherwise.

As used herein, the terms "comprise," "comprise," "include," and/or "contain" describe functions, integers, steps, operations, elements, and/or , specifies the presence of components, but does not preclude the presence or addition of one or more other functions, integers, steps, operations, elements, components, and/or groups thereof. Unless defined otherwise, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Moreover, terms used herein are to be construed to have a meaning consistent with their meaning in the context of the specification and the relevant art, and unless expressly defined herein, an ideal meaning or It will be understood not to be construed in an overly formal sense.

10 Intravenous catheter device 12 Catheter hub 14 Catheter tube/catheter 16 Needle hub 18 Proximal end 20 Distal end 21 Needle 22 Needle shaft 24 Needle tip 26 Lumen 28 Aperture or hole 30 Space 32 Beveled cut/Beveled radius cut 34 bevel 36 engaging means 38 needle guard 40 base portion 42 first arm 44 second arm 46 through hole A axial direction L length W width R radius

Claims (21)

An intravenous (IV) catheter (10) device comprising:
a tubular catheter (14) having a proximal end (18) and a distal end (20) and attached to a catheter hub (12);
A needle (21) defining an axial direction (A) having a wall defining a lumen (26), a bevel (34) and a needle tip (24) at the distal end (20). a needle (21) comprising a shaft (22) and a needle hub (16) attached to a proximal end (18) of the needle shaft (22);
a needle guard (38) movably disposed on the needle shaft (22),
The needle shaft (22) extends within the tubular catheter (14) and the needle tip (24) of the needle (21) extends into the distal end (20) of the tubular catheter (14). protruding from
Said needle (21) has engagement means (36) adapted to engage said needle guard (38) to prevent said needle tip (24) from slipping out of said needle guard (38). equipped with
said needle (21) has at least one opening (28) with at least one beveled cut (32);
Intravenous catheter (10) device. Said opening (28) has a beveled cut (32) of increasing angle (X) towards the proximal end (18) of said needle (21) in the opposite direction of said needle tip (24). A catheter device (10) according to claim 1. Said opening (28) has at least one beveled cut (32) at an angle (X) of increasing value towards the distal end (20) of said needle (21) in the direction of said needle tip (24). A catheter device (10) according to claim 1, comprising: said opening (28) is formed by two angled cuts (32),
one of said angled cuts increases in angle (X) towards the proximal end (18) of said needle (21) in the opposite direction of said needle tip (24);
2. The second angled cut (32) has an angle (Y) of increasing value towards the distal end (20) of the needle (21) in the direction of the needle tip (24). A catheter device (10) according to claim 1. A catheter device (10) according to any one of the preceding claims, wherein the angles (X) and (Y) of the angled cuts are in the range of 0° to 89°. A catheter device (10) according to any one of the preceding claims, wherein the openings have varying dimensions of length (L) and width (W). The opening (28) having at least one beveled radius cut (32) having a radius (R), the radius (R) of the beveled cut (32) having varying lengths. 2. The catheter device according to 1. 5. A catheter device (10) according to claim 4, wherein the two angled cuts (32) have a point of intersection at the center of the length (L). 5. A catheter device (10) according to claim 4, wherein the two angled cuts (32) have intersections with regions between which the regions are straight or angled. The catheter device according to any one of claims 1 to 9, wherein the angles (X) and (Y) are in the range of 0° to 89°, with or without the radius of inclination (R). 10). Said beveled cut (32) of said opening (28) has a suitable shape, including substantially oval, oval, square, rectangular, triangular, circular, polygonal, irregular. A catheter device (10) according to any one of claims 1 to 10 comprising. The opening (28) may face the needle shaft substantially in the same, opposite, perpendicular or offset direction as the bevel (34) of the needle (21) faces. A catheter device (10) according to any one of claims 1 to 11, positionable at (22). A catheter device (10) according to claim 1, wherein said opening (28) is provided near said needle tip (24). A catheter device (10) according to claim 1, wherein the distance between the needle tip (24) and the opening (28) is configured such that the opening is covered by the catheter tube (14). A catheter apparatus (10) according to claim 1, wherein the opening (28) can be located anywhere from proximal to the needle tip (24) to distal to the catheter hub (12). A catheter device (10) according to claim 1, wherein said aperture (28) is provided between said engagement means (26) and said needle tip (24). A catheter device (10) according to claim 1, wherein said engagement means (26) is provided between said needle tip (24) and said opening (28). A catheter device (10) according to claim 1, wherein said opening (28) has two sides, one side being straight and the other side being beveled. Said opening or hole (28) can be located at any position of 360° around said needle shaft (22) except at the bottom of said needle shaft (22) in the direction opposite to the bevel (34) of said needle (21). 2. A catheter device (10) according to claim 1, provided in a. A catheter device (10) according to claim 1, wherein said openings or holes (28) have a perforated shape forming an opening of sufficient size to allow flashback of blood. A catheter device (10) according to claim 1, wherein one or more openings or holes (28) are provided in said needle shaft (22).

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